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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000048505 |
Receipt No. | R000055275 |
Scientific Title | Trial of music therapy for the subjects |
Date of disclosure of the study information | 2022/08/01 |
Last modified on | 2022/07/28 |
Basic information | ||
Public title | Study of music therapy in Integrative Medicine | |
Acronym | Performance and evaluation of music therapy | |
Scientific Title | Trial of music therapy for the subjects | |
Scientific Title:Acronym | Trial of music therapy | |
Region |
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Condition | ||||
Condition | Healthy and various diseases | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Clinical effect of music |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | QOL, ADL, vitals, markers of five senses and several factors related to music and medicine (baseline and 12 weeks later, evaluated factors include various biomarkers) |
Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
Interventions/Control_2 | |
Interventions/Control_3 | |
Interventions/Control_4 | |
Interventions/Control_5 | |
Interventions/Control_6 | |
Interventions/Control_7 | |
Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Subjectives with no remarkable problems of QOL/ADL | |||
Key exclusion criteria | Subjectives with remarkable problems of QOL/ADL | |||
Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Medical research | ||||||
Division name | Medical and music division | ||||||
Zip code | 7700943 | ||||||
Address | Nakashowa 1-61, Tokushima, Japan | ||||||
TEL | 09031872485 | ||||||
pianomed@bronze.ocn.ne.jp |
Public contact | |||||||
Name of contact person |
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Organization | Medical research/Tokushima Univ | ||||||
Division name | Medical and music division | ||||||
Zip code | 770 | ||||||
Address | Nakashowa 1-61, Tokushima 770-0943 JAPAN | ||||||
TEL | 819031872485 | ||||||
Homepage URL | |||||||
pianomed@bronze.ocn.ne.jp |
Sponsor | |
Institute | Medical research |
Institute | |
Department |
Funding Source | |
Organization | Medical research |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Medical research |
Address | Nakashowa 1-61, Tokushima, Japan |
Tel | 09031872485 |
pianomed@bronze.ocn.ne.jp |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Collaboration with other research of music therapy and medical practice |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055275 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |